Hologic, Inc: 26 recalls on record

Recalls filed with 1 agency: FDA (26).

First recall on record: October 3, 2012. Most recent: May 20, 2026.

Risk classification: Class I: 2 · Class II: 24

Most recent recalls

DateAgencyProduct
May 20, 2026FDASELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-…Z-2167-2026
May 20, 2026FDA3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SY…Z-2168-2026
May 6, 2026FDABrand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco M…Z-1949-2026
February 12, 2025FDAThe Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Sp…Z-1095-2025
January 1, 2025FDAPanther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400Z-0694-2025
December 18, 2024FDAHologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical ins…Z-0669-2025
December 4, 2024FDABioZorb Marker. Radiographic soft tissue marker.Z-0328-2025
October 2, 2024FDASelenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions…Z-3248-2024
July 24, 2024FDAHorizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizo…Z-2373-2024
May 15, 2024FDABioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites…Z-1733-2024
April 3, 2024FDAAptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 A…Z-1371-2024
January 31, 2024FDAPANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic aci…Z-0782-2024
April 13, 2022FDAPanther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagno…Z-0877-2022
March 4, 2020FDASelenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry,…Z-1343-2020
October 25, 2017FDAPanther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagn…Z-0027-2018
August 9, 2017FDATomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample proce…Z-2864-2017
September 14, 2016FDASureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-O…Z-2766-2016
May 4, 2016FDAHologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.Z-1580-2016
June 11, 2014FDAHologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic ima…Z-1701-2014
June 11, 2014FDAHologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, S…Z-1700-2014
March 5, 2014FDANovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Mode…Z-1094-2014
October 9, 2013FDASelenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x T…Z-2301-2013
May 22, 2013FDAFluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is…Z-1327-2013
May 22, 2013FDAFluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-…Z-1326-2013
October 3, 2012FDAHologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The…Z-2452-2012

Questions about this company

How many recalls does Hologic, Inc have?
Recalert has 26 U.S. recalls on record for Hologic, Inc, published between October 3, 2012 and May 20, 2026.
What was the most recent Hologic, Inc recall?
FDA recall Z-2167-2026, published May 20, 2026: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2,…
Which agencies have handled Hologic, Inc recalls?
Hologic, Inc appears as the recalling firm in recalls from: FDA (26).

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